The present invention relates to a device which delivers a medicament in the upper aerodigestive tract, and specifically, to the oral cavity. More particularly, the present invention relates to an appliance for delivering antibiotics, topical steroids, local anesthetics and other medicaments in the upper aerodigestive tract at therapeutically effective dosage levels which also stabilizes an endotracheal tube extending therethrough and which is sized and dimensioned so as to be stabilized in the oral cavity by engagement of the tongue and the mucosa of the oral cavity.
Recent advances in medical science have led to a proliferation of invasive monitoring methodologies and therapeutic techniques. Such techniques include endotracheal and nasogastric tubes and urinary, arterial, venous, cardiac and pulmonary artery catheters. Prosthetic and therapeutic implant devices, such as vascular and central nervous shunts, orthopaedic-dental implants, and pacemakers have also become common.
With these advances, complications have also arisen; the primary complication is infection. Statistics indicate that forty-five percent of the 2,000,000 nosocomial infections that occur annually in the United States are device related. Measures such as local care and systemic antibiotics have proven less than totally effective in preventing such infections.
In addition, current therapeutic modalities for the treatment of patients with ulcerative and vesicula-bullous lesions involving oral mucosa are ineffective. The most troublesome of these conditions are recurrent aphthous stomatitis, lichen planus, pemphigus vulgaris, oral mucous membrane pemphigoid, lichenoid drug eruption, hypersensitivity mucositis, and traumatic mucositis. Many of these conditions show a favorable, often dramatic, response to topical and/or systemic steroid therapy. Most, however, do not justify administration of systemic steroids.
Although topical steroids offer an alternative mode of therapy for such lesions, their use has been less than satisfactory due to the inability to maintain intimate contact of the pharmacologic agent against the involved lesion for a therapeutically effective period of time due to the moist nature of the oral environment. Some efforts to overcome this problem have been made using mucoadhesives such as ORABASE (tm). Although widely used, these agents are generally less than optimal in their efficacy due to the salivary flow and motion associated with speech, mastication, and deglutition, all of which tend to rapidly dilute and/or eliminate the active medicament. In addition, the anatomical features and location of many mucosal lesions limit the ability to apply topical agents to the involved area.
Attempts have been made to provide devices which overcome such problems. Illustrative are certain prior art references which disclose the incorporation of medicaments such as antimicrobials into biocompatible polymers, and the fashioning of such polymers into invasive and/or indwelling devices. For instance, U.S. Pat. No. 4,479,795 (Mustacich, et al.) describes a polymer having an antimicrobial agent releasably incorporated therein said to be capable of being used for the manufacture of urinary and intravenous catheters, the antimicrobial agent diffusing from the polymer to inhibit bacterial infection once the device is in place. Similarly, U.S. Pat. No. 4,309,996 (Theeuwes) describes a drug delivery system consisting of a microporous wall surrounding a compartment containing a drug which releases the drug in a fluid environment. However, such references lack any teachings of how to deliver an effective dosage of the incorporated medicament in the upper aerodigestive tract while also stabilizing the device into which the medicament is incorporated in the patient's oral cavity once it is inserted.
Also of interest are U.S. Pat. Nos. 3,566,874 (Shepherd, et al.) and 4,515,593 (Norton). The Shepherd, et al. patent discloses a catheter coated with a hydrophilic acrylate or methacrylate polymer that is said to reduce the irritation and infection accompanying the use of catheters and which can be absorbed with an antibiotic. Norton describes a catheter having a portion of the exterior surface coated with a hydrophilic elastomer for reception of a microbicide. These references likewise lack a teaching of the delivery of a therapeutically effective dose of the medicament in the upper aerodigestive tract while also stabilizing the device in the oral cavity of the patient.
Certain prior art does appear to teach stabilizing an indwelling device in the patient. For instance, U.S. Pat. Nos. 4,326,515 (Shaffer, et al.), 4,520,813 (Young) and 3,927,676 (Schultz) describe external devices for securing an endotracheal tube in place in the oral cavity of a patient. The effectiveness of such devices can be summed up by stating that, so far as is known, it is often necessary to use adhesive tape, in addition to the device, to adequately stabilize the endotracheal tube. Further, those references include no suggestion whatsoever of delivering an effective dose of a selected medicament in the upper aerodigestive tract, much less the topical application of the medicament to the mucosa of, for instance, the oral cavity.
In sum, all the devices of which Applicants are aware are characterized by one or more limitations such that there is a need for an apparatus and method for topical drug therapy for conditions including, but not limited to, infections associated with indwelling appliances such as nasogastric and endotracheal tubes, the lesions listed above, oral and/or pharyngeal tumors, viral eruptions, and any other condition which benefits from the high concentrations of an appropriate medicament that can be maintained in intimate contact with the involved tissue(s) over prolonged and controlled periods of time. It is, therefore, an object of the present invention to provide such an apparatus.
Another object of the present invention is to provide an intraoral drug delivery appliance containing neat and/or encapsulated antimicrobial agent(s) to provide sustained release of the agent(s) at antimicrobially effective levels.
Another object of the present invention is to reduce or eliminate infection associated with the use of indwelling appliances in the upper aerodigestive tract.
Another object of the present invention is to provide an apparatus for delivery of a medicament in the upper aerodigestive tract which can be introduced or removed from the oral cavity of an intubated patient without extubating the patient.
Still another object of the present invention is to provide an apparatus which is capable of topical application of a medicament to the mucosa of the oral cavity or to other specific locations in the upper aerodigestive tract of the patient.
Another object of the present invention is to provide a method and apparatus for stabilizing an endotracheal tube in the oral cavity of a patient.
Other objects, and the advantages, of the present invention will be made clear by the following description of the presently preferred embodiments of appliances constructed in accordance with the invention.